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This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Erlotinib | Experimental | Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment. |
|
| Late Erlotinib | Placebo Comparator | Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died During the Overall Study | Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated. | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) |
| Overall Survival (OS) as Median Time to Event During the Overall Study | Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months. | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) |
| Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study | Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated. | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment | Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilroy | California | 95020 | United States | |||
The study consisted of three periods: a Blinded Phase (BP), an Open-Label Phase (OLP), and final Survival Follow-Up (SFU). These periods were not necessarily sequential, because the OLP could be "skipped" in select participants. Therefore, the reasons for discontinuation are presented altogether within the Overall Study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Late Erlotinib | Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Erlotinib | Drug | Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo. |
|
|
| Second-Line Chemotherapy | Drug | Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator. |
|
| Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks. | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated. | At 6 months |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method. | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method. | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method. | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Kansas City | Missouri | 64132 | United States |
| Missoula | Montana | 59802 | United States |
| Lebanon | New Hampshire | 03756 | United States |
| Dayton | Ohio | 45420 | United States |
| Chattanooga | Tennessee | 37404 | United States |
| Spokane | Washington | 99218 | United States |
| Tacoma | Washington | 98405 | United States |
| Belo Horizonte | Minas Gerais | 30150-281 | Brazil |
| Lajeado | Rio Grande do Sul | 95900-000 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90470340 | Brazil |
| Ijuà | Rondônia | 98700-000 | Brazil |
| Florianópolis | Santa Catarina | 88034-000 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| Gabrovo | 5300 | Bulgaria |
| Haskovo | 6300 | Bulgaria |
| Plovdiv | 4004 | Bulgaria |
| Rousse | 7000 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1303 | Bulgaria |
| Sofia | 1527 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Sofia | 1784 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Windsor | Ontario | N8W 2X3 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Québec | Quebec | G1V 4G5 | Canada |
| Regina | Saskatchewan | S4T 7T1 | Canada |
| Beijing | 100142 | China |
| Beijing | 100730 | China |
| Changchun | 130012 | China |
| Fuzhou | 350014 | China |
| Guangzhou | 510515 | China |
| Guangzhou | China |
| Harbin | 150081 | China |
| Shanghai | 200030 | China |
| Shanghai | 200433 | China |
| Shantou | 515041 | China |
| Shenyang | 110001 | China |
| Suzhou | 215004 | China |
| Tianjin | 300060 | China |
| Wuhan | 430071 | China |
| Xi'an | 710061 | China |
| České Budějovice | 370 87 | Czechia |
| Jindřichův Hradec | 377 01 | Czechia |
| Nymburk | 288 01 | Czechia |
| Ostrava - Poruba | 708 52 | Czechia |
| Prague | 150 06 | Czechia |
| Prague | 180 81 | Czechia |
| Tábor | 390 03 | Czechia |
| Bayonne | 64109 | France |
| Compiègne | 60321 | France |
| Gap | 05007 | France |
| Libourne | 33505 | France |
| Lille | 59020 | France |
| Nantes | 44202 | France |
| Saint-Brieuc | 22027 | France |
| Villefranche-sur-Saône | 69655 | France |
| Budapest | 1121 | Hungary |
| Budapest | 1122 | Hungary |
| Budapest | 1125 | Hungary |
| Budapest | 1145 | Hungary |
| Deszk | 6772 | Hungary |
| Farkasgyepű | 8582 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5703 | Hungary |
| Mátraháza | 3233 | Hungary |
| Miskolc | 3526 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szolnok | 5000 | Hungary |
| Törökbálint | 2045 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| S. Giovanni Rotondo | Apulia | 71013 | Italy |
| Avellino | Campania | 83100 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Parma | Emilia-Romagna | 43100 | Italy |
| Rome | Lazio | 00144 | Italy |
| Rome | Lazio | 00151 | Italy |
| Rome | Lazio | 00168 | Italy |
| Legnago | Lombardy | 37045 | Italy |
| Treviglio | Lombardy | 24047 | Italy |
| Livorno | Tuscany | 57124 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Verona | Veneto | 37134 | Italy |
| Daugavpils | 5417 | Latvia |
| Riga | LV-1079 | Latvia |
| Riga | LV1002 | Latvia |
| Kaunas | 50009 | Lithuania |
| Vilnius | 08660 | Lithuania |
| Arnhem | 6800 TA | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Hoorn | 1625 HV | Netherlands |
| Sittard-Geleen | 6162 BG | Netherlands |
| Zutphen | 7207 AE | Netherlands |
| Brzozów | 36-200 | Poland |
| Krakow | 31-115 | Poland |
| Poznan | 60-569 | Poland |
| Wodzisław Śląski | 44-300 | Poland |
| Zamość | 22-400 | Poland |
| Baia Mare | 430031 | Romania |
| Brasov | 500091 | Romania |
| Brasov | 500152 | Romania |
| Brăila | 810325 | Romania |
| Bucharest | 010976 | Romania |
| Bucharest | 022328 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Cluj-Napoca | 400058 | Romania |
| Cluj-Napoca | 400132 | Romania |
| Oradea | 410167 | Romania |
| PloieÅŸti | 100337 | Romania |
| Târgu Mureş | 540136 | Romania |
| Banská Bystrica | 975 17 | Slovakia |
| Bardejov | 085 01 | Slovakia |
| Košice | 04001 | Slovakia |
| Nové Zámky | 940 02 | Slovakia |
| Poprad | 058 01 | Slovakia |
| Rimavská Sobota | 97901 | Slovakia |
| Cape Town | 7570 | South Africa |
| Cape Town | 7700 | South Africa |
| George | 6530 | South Africa |
| Port Elizabeth | 6045 | South Africa |
| Pretoria | 0002 | South Africa |
| Gyeonggi-do | 463-707 | South Korea |
| Seoul | 03722 | South Korea |
| Seoul | 06351 | South Korea |
| Seoul | 150-713 | South Korea |
| Suwon | 442-723 | South Korea |
| Kaohsiung City | 00833 | Taiwan |
| Taichung | 40447 | Taiwan |
| Taichung | 40705 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 112 | Taiwan |
| Taipei | 11490 | Taiwan |
| Bangkok | 10700 | Thailand |
| Hat Yai | 90110 | Thailand |
| Muang | 50200 | Thailand |
| Muang | 57000 | Thailand |
| Dnipropetrovsk | 49102 | Ukraine |
| Donetsk | 83092 | Ukraine |
| Kharkiv | 61024 | Ukraine |
| Kirovograd | 25011 | Ukraine |
| Kyiv | 03022 | Ukraine |
| Kyiv | 03115 | Ukraine |
| Kyiv | 04107 | Ukraine |
| Lutsk | 63000 | Ukraine |
| Sumy | 40005 | Ukraine |
| Uzhhorod | 88000 | Ukraine |
| Vinnytsia | 21029 | Ukraine |
| Zaporizhzhya | 69040 | Ukraine |
| FG001 | Early Erlotinib | Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol. |
| COMPLETED |
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| NOT COMPLETED |
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|
Intent-to-Treat (ITT) Population: All participants who were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Late Erlotinib | Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol. |
| BG001 | Early Erlotinib | Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Died During the Overall Study | Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated. | ITT Population. | Posted | Number | percentage of participants | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) as Median Time to Event During the Overall Study | Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months. | ITT Population. | Posted | Median | 95% Confidence Interval | months | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death) |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study | Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | At 1 year |
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| Secondary | Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment | Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated. | ITT Population. | Posted | Number | percentage of participants | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
|
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| Secondary | Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks. | ITT Population. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
|
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| Secondary | Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months |
|
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| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment | Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method. | ITT Population. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP) |
|
Up to approximately 4.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until disease progression, death, or unacceptable toxicity during BP; per local standards and 28 days after last visit during OLP)
Safety Population: All participants who received at least one dose of study treatment, according to drug actually received. Non-serious adverse events (NSAEs) were not collected in the OLP. Hence, 0 participants would be affected and at risk in "Other (Not Including Serious) Adverse Events". However, an NSAE in 1 participant was reported to Roche outside protocol (see "Rash"). Other NSAEs that may have occurred during the OLP are not included in the table because they were not reported to Roche.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Late Erlotinib) | Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. | 27 | 319 | 107 | 319 | ||
| EG001 | Erlotinib (Early Erlotinib) | Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. | 36 | 322 | 206 | 322 | ||
| EG002 | Second-Line Erlotinib (Late Erlotinib) | Participants who received blinded placebo and who demonstrated disease progression were unblinded and could receive second-line erlotinib as 150-mg tablets PO once daily, provided by the Sponsor. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity. | 23 | 248 | 1 | 1 | ||
| EG003 | Second-Line Chemotherapy (Early Erlotinib) | Participants who received blinded erlotinib and who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity. | 8 | 162 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Tracheal obstruction | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemorroids thrombosed | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA (18.0) | Non-systematic Assessment |
| |
| Meningeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment | Per protocol, NSAEs were not collected in the OLP. However, an NSAE in 1 participant in the "Second-Line Erlotinib (Late Erlotinib)" arm was reported outside protocol and coded with MedDRA (18.1). As such, this single event is presented in the table. |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Following the final analysis, the study was closed and all remaining participants were withdrawn from the study and considered "Not Completed" (as presented in the Participant Flow). However, the overall status of study was confirmed as completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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